MR-107A-02 for Postoperative Pain

Recruiting at18 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mylan Specialty, LP

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called MR-107A-02 to see if it can safely and effectively reduce pain in patients who have had hernia surgery.

Research Team

Susanne Vogt

Principal Investigator

Viatris Inc.

Eligibility Criteria

This trial is for individuals experiencing acute pain after undergoing herniorrhaphy, which is surgery for a hernia repair. Specific eligibility criteria are not provided, but typically participants must be adults who have just had this surgery and meet certain health standards.

Inclusion Criteria

Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.

My health is good enough for surgery according to the ASA scale.

I experienced moderate to severe pain after surgery.

Exclusion Criteria

Body mass index (BMI) >40 kg/m2 at screening.

I have been treated with MR 107A 02 before.

I have had surgery for an inguinal hernia in the last 2 years.

Treatment Details

Interventions

• MR-107A-02 (Other)

Trial Overview The study is testing the effectiveness and safety of a medication called MR-107A-02 in managing post-surgery pain. It's being compared to Tramadol, a known pain reliever, and a placebo (a substance with no active drug).

Participant Groups

Group I: MR-107A-02 Experimental Treatment 1 Intervention

15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .

Group II: Tramadol Active Control 2 Interventions

50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization). Placebo will be administered during out patient phase.

Group III: Placebo Placebo Group 1 Intervention

Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.

Who Is Running the Clinical Trial?

Mylan Specialty, LP

Lead Sponsor

Trials

4

Recruited

1,200+